The Neurospan Bridge: A Device for Peripheral Nerve Repair

Neurospan 桥：一种用于周围神经修复的装置

基本信息

批准号：
10515280
负责人：
Yacov Koffler
金额：
$ 100万
依托单位：
AUXILIUM BIOTECHNOLOGIES INC.
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-03-15 至 2024-02-29
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10515280
关键词：
Acceleration Agreement Allografting Animal Model Autologous Autologous Transplantation Biomedical Engineering Biomimetics Biotechnology Clinic Clinical Clinical Research Clinical Trials Data Development Device or Instrument Development Devices Dimensions Distal Exhibits Facial Nerve Injuries Fascicle Functional Regeneration Hand Human Industry Infrastructure Injury Institutional Review Boards Label Leg Length Licensing Marketing Medical Care Costs Medical Device Modeling Morbidity - disease rate Muscle Nerve Neurology Neuroma Operative Surgical Procedures Outcome Patients Peripheral Nerves Peripheral nerve injury Phase Phase II Clinical Trials Process Quality of life Ramp Recovery Reporting Safety Site Source Spinal Cord Sterilization Structure Surgeon Technology Testing Therapeutic Equivalency Time Toxicology Trauma Tube Vendor Weight Work axon regeneration chronic pain clinical implementation clinical research site combat injury commercialization cost cost effective design verification follow-up improved interest limb injury manufacture manufacturing process meetings nerve autograft nerve gap nerve injury nerve repair neurosurgery participant enrollment peripheral nerve repair pre-clinical preclinical development preclinical study programs scaffold standard of care sural nerve wound

项目摘要

Peripheral Nerve Injury (PNI) occurs in 3% of all trauma cases and 30% of combat injuries to the extremities, resulting in a loss of five million working days each year and costs of $150 billion annually in the U.S. The standard of care in the clinic is a nerve autograft from the patients’ leg. The NeuroSpan Bridge is a unique, biomimetic, multi-channel scaffold that maintains linearity throughout the structure, thus accelerating and guiding regenerating axons precisely to their targets on the distal end of the transected nerve. It has been extensively tested in gaps up to 3cm-long and demonstrated superiority to existing devices in a short-gap animal model, and superiority to nerve autograft in a long-gap animal model. This project will put in place a program to finalize pre-clinical studies, submit an IDE application to the FDA and carry out a feasibility clinical study followed by 510(k) application. The proposed project brings together experts in peripheral nerve injury, axonal regeneration, neurology, neurosurgery and bioengineering to develop a practical, cost-effective, consistent, and transnationally relevant medical device for the treatment of peripheral nerve injury.

周围神经损伤 (PNI) 发生在所有外伤病例中的 3% 以及战斗伤害中的 30% 四肢，每年造成 500 万个工作日的损失和 150 美元的费用在美国每年有 10 亿美元。诊所的护理标准是来自自体神经移植 NeuroSpan 桥是一种独特的仿生多通道支架。保持整个结构的线性，从而加速和引导轴突再生精确地到达横断神经远端的目标。在长达 3 厘米的间隙中，并在短间隙动物中表现出优于现有设备的优越性模型，以及在长间隙动物模型中神经自体移植的优越性。制定计划以完成临床前研究，向 FDA 提交 IDE 申请并携带拟议项目带来了 510(k) 申请后的可行性临床研究。聚集了周围神经损伤、轴突再生、神经病学、神经外科和生物工程开发实用的、具有成本效益的、一致的和跨国相关的用于治疗周围神经损伤的医疗设备。